BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARADRIVE STEERABLE SHEATH CLEAR

    MDR report key: 23742837 · Received December 8, 2025

    Report

    Report Number
    2124215-2025-89535
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    August 7, 2025
    Report Date
    December 8, 2025
    Manufacturer
    FARAPULSE, INC.
    Product Code
    DRA
    UDI-DI
    00810087180072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE TECHNICAL ANALYSIS: THE RETURNED FARADRIVE SHEATH OBSERVED A SUCCESSFUL INSERTION DURING DEVICE-TO-DEVICE INTERACTION WITH THE NATIVE DILATOR. THE ID AND OD DIMENSIONS OF THE FARADRIVE SHAFT AND DILATOR WERE MEASURED AND RESULTED IN PASSING MEASUREMENTS. MICROSCOPIC EXAMINATION OF THE SHEATH TIP OBSERVED NOTABLE DEFORMATIONS ALONG THE OUTER DIAMETER. THE DISTAL END OF THE SHEATH TIP EXHIBITED A BULBOUS APPEARANCE, RESULTING IN LACK OF A TAPERED SHAPE. THE OUTER DIAMETER EXHIBITED INCREASED THICKNESS AND A FLATTENED PROFILE, RESULTING IN A PRONOUNCED STEP TRANSITION AND GAP AT THE INTERFACE BETWEEN THE DILATOR OD AND SHEATH TIP ID WHEN THE DILATOR WAS INTRODUCED. ADDITIONALLY, MICROSCOPIC EXAMINATION OF THE DILATOR OBSERVED THE TIP WAS DAMAGED. BASED ON THE COMPLAINT SUMMARY, THIS DEFECT WAS LIKELY CAUSED BY INSERTION INTO THE SHEATH.

    Description of Event or Problem · 0

    REPORTABLE BASED ON ANALYSIS COMPLETED ON 13 NOVEMBER 2025. IT WAS REPORTED THAT DURING THE PULSE FIELD ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION FARADRIVE STEERABLE SHEATH CLEAR WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT SHEATH (CL13645 #1) WAS PREPARED, FLUSHED WITH NO ISSUE. CATHETER (8022258) WAS OPENED AND PREPARED WITH NO ISSUE. GUIDEWIRE INSERTED AND DOCTOR TESTED CATHETER. SLIDER WAS FOUND TO BE VERY STIFF AND THE PHYSICIAN COULD NOT PUSH SLIDER SMOOTHLY TO GET INTO FLOWER. THE PHYSICIAN TRIED TO TEST SLIDER MULTIPLE TIMES BUT TO NO AVAIL. SLIDER WAS STILL VERY STIFF. IN THE INTEREST OF PATIENT SAFETY, A SECOND CATHETER WAS OPENED. FIRST SHEATH WAS USED AND INSERTED INTO PATIENT. THE PHYSICIAN FELT RESISTANCE IN PATIENT. UNDER FLOUROSCOPY, THE SHEATH WAS NOT ABLE TO BE PUSHED INTO PATIENT. DOCTOR USED A DILATOR TO INCREASE SIZE OF OPENING BUT TO NO AVAIL. DOCTOR FEELS THAT THERE IS AN ISSUE WITH THE DILATOR AND SHEATH WHICH IS CAUSING RESISTANCE TO INSERTION. IN THE INTEREST OF PATIENT SAFETY, A SECOND SHEATH WAS OPENED (CL13645 #2). SECOND SHEATH WAS PREPARED AND FLUSHED WITH NO ISSUE. PHYSICIAN TRIED TO INSERT THE SHEATH BUT AGAIN FACED RESISTANCE. HOWEVER, WITH REPEATED DILATIONS, PHYSICIAN WAS FINALLY ABLE TO PUSH SHEATH UP PATIENT AND INTO THE HEART. THE SHEATH AND DILATOR WERE NOT ALLOWING SMOOTH INSERTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ALTERNATIVE METHOD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE PRODUCT IS EXPECTED TO BE RETURNED. ANALYST REVEALED THE DIALATOR TIP WAS FLARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2421523 FARADRIVE STEERABLE SHEATH CLEAR CATHETER, STEERABLE DRA FARAPULSE, INC. CL13645 00810087180072

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown